Shots: The P-I study assesses the safety, tolerability and PK/PD of VENT-02 (oral), a brain-penetrant NLRP3 inhibitor, in a range of single and multiple ascending doses among healthy volunteers The study showed that VENT-02 was well-tolerability without any DLTs or SAEs with only mild or moderate TRAEs, achieved 100% IL-1β inhibition in ex vivo whole blood challenge assay & significant drug levels in CSF for 24hrs. plus reduced hsCRP as well as indicated potential of QD dosing Furthermore, the company anticipates the commencement of the P-Ib study for Parkinson’s disease in H2’24 & the ..read more

Shots: IGM Biosciences and Sanofi have revised the previous exclusive worldwide agreement to solely develop 3 immunology/inflammation targets. IGM will keep the worldwide rights to its technology related to the oncology targets nominated by Sanofi Under the agreement, IGM will be responsible for the research & development of the targets covering the cost of P-I study for up to two constructs per target. Sanofi will handle further development & commercialization activities & related costs IGM is entitled to receive a total of ~$1,065M as development, regulatory & commercial mile ..read more

Shots: Artiva has dosed the first patient with AlloNK (AB-101) in P-I study assessing its safety & clinical activity combined with rituximab or obinutuzumab in patients who failed treatment for class III/IV LN. The company will partner with Lupus Therapeutics for the trial The company’s AlloNK was further analyzed in P-I/II combined with rituximab for r/r B-NHL that demonstrated its ability of B-cell depletion to reset the immune system in all 29 patients, supporting the MOA. CRs were also seen in patients, suggesting its efficacy to treat autoimmune diseases due to common lymphoid tissue ..read more

Shots: Essential Pharma has completed the acquisition of Reminyl oral capsules from Janssen Pharmaceutica to treat mild to moderately severe dementia of the Alzheimer type expanding its CNS medicines portfolio Through the acquisition, Essential Pharma has obtained rights to Reminyl across the EEA, Thailand, South Korea and all other current markets for the product except UK, Ireland, Japan & Latin America Reminyl is a cholinesterase inhibitor from the company’s CNS drug portfolio developed as a treatment of mild to moderately severe Alzheimer’s dementia Ref: Essential Pharma |&nb ..read more

Shots:  Sticking on to M&A and licensing agreements can be really challenging especially when you deal with stringent antitrust law and evolving regulatory challenges. In such adverse scenarios, the rational and the right step seems to be nullifying the existing deal  In 2023, the deal termination between Janssen and Arrowhead remained the talk of the town and garnered the most attention in the biopharma fraternity by being the most valued deal to be terminated with a staggering amount of $3.75B followed by Fate Therapeutic's deal with Janssen Biotech and BeiGene's deal with Nova ..read more

Shots: The P-III (SURMOUNT-OSA) trial assessed the safety & efficacy of tirzepatide (10mg or 15mg, QW) vs PBO to treat moderate-to-severe OSA & obesity adults under which study 1 was for those not using PAP therapy while study 2 was for those using & continuing PAP therapy The study 1 results demonstrated a reduction in the mean AHI of 27.4 vs 4.8 events per hour while the 2EPs showed a reduced mean AHI of 55.0% vs 5.0% and a reduced mean body weight of 18.1% vs 1.3% from baseline to 52wks. Furthermore, the study 2 results demonstrated a reduction in the mean AHI of 30.4 vs 6.0 eve ..read more

Shots: The P-III (EAGLE-1) study assessed the safety & efficacy of gepotidacin (2 doses of 3,000mg, oral) vs ceftriaxone (500mg, IM) + azithromycin (1,000mg) to treat uncomplicated urogenital gonorrhoea patients (n=~600). 1EP was microbiological response at the ToC visit 3-7 days post treatment The study demonstrated drug’s non-inferiority with a success rate of 92.6% vs 91.2% for the combination of ceftriaxone & azithromycin Moreover, the company concluded EAGLE-2 & EAGLE-3 studies assessing the safety & efficacy of gepotidacin (1,500mg, oral, BID for 5 days) vs nitrofurantoin ..read more

Shots: The Disease of the Month report by PharmaShots aims to integrate an advanced approach to disease analysis. The report delves deep into the epidemiology, market size, disease management, available therapies, and key players involved For the April edition of the Disease of the Month report, PharmaShots brings an enlightening guide to Duchenne Muscular Dystrophy, a genetic problem that causes muscles to weaken and atrophy The condition most commonly affects children between 3 and 6 years of age   Introduction1,2,3,4,5 Duchenne muscular dystrophy is an inherited disorder that results f ..read more

Shots: Medincell and AbbVie have entered into a strategic licensing agreement to co-develop & commercialize up to 6 candidates by utilizing Medincell's long-acting injectable technology platform. The 1st LAI program is selected with its formulation underway Under the agreement, Medincell is entitled to receive $35M up front, $1.9B development & commercial milestones ($315M each) along with mid-single to low-double-digit net-sales-based royalties Furthermore, Medincell will be responsible for formulation activities & preclinical development to advance the candidates into clinical ev ..read more

Shots: The P-III (OCARINA II) trial assesses the safety, PK profile as well as radiological & clinical effects of Ocrevus (920mg, SC) vs Ocrevus (IV) to treat patients (n=236) with relapsing MS (RMS) or primary progressive MS (PPMS) The updated, long-term data demonstrated a near-complete relapse activity suppression (97% had no relapse) & reduced MRI at 48wks. as well as an ARR of 0.04 with patients showing no T1 Gd+ & new/enlarging T2 lesions. Exploratory patient reported outcomes (n=52) suggested high satisfaction (92.3%) & convenience (90.1%) with Ocrevus SC injection Moreo ..read more